FDA 483 - Iridex Corporation - September 20, 2023

During an inspection conducted from September 6 to September 20, 2023, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Iridex Corporation, a medical device manufacturer based in Mountain View, CA. The inspection identified several significant observations indicating non-compliance with federal quality system regulations for medical devices.

The primary issues observed included inadequate complaint handling procedures. Specifically, the company failed to conduct necessary device history record reviews for complaints where serial or lot numbers were provided but the device was not returned for investigation. Furthermore, Iridex did not perform timely complaint trending or approve a health hazard evaluation concerning a significant increase in reported injuries for certain devices, such as the MicroPulse P3 Probe.

Deficiencies were also noted in the company's corrective and preventive action (CAPA) system, as a CAPA was initiated with a significant delay despite a clear increase in product complaints. Additionally, the FDA found that multiple individual medical device manufacturer reports (MEDWATCH Form FDA 3500A) submitted by Iridex were incomplete. These reports lacked essential patient demographic information, such as gender, age, weight, ethnicity, and race, and did not include the date received by the manufacturer or the report type.

Iridex Corporation has indicated a promise to correct these observations. The company is required to submit a comprehensive response detailing its implemented and planned corrective actions to address these regulatory shortcomings.